Here at Syneos Health
we are currently recruiting for a Medical Director with experince in pulmonology and / or infectious disease.
provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical
Essential Functions and responsibilities for this role are as follows :
1. Manages subject safety and the scientific integrity of clinical trials.
2. Responsible for subject-safety and the scientific integrity of clinical trials.
3. Performs the duties of a Medical Monitor.
4. Provides 24-hour coverage for clinical trials.
5. Participates in bids, bid-defenses & feasibility assessments when requested.
6. Provides project-specific and therapeutic training to sponsors and Company staff as needed.
7. Works with the Drug Safety Department by providing medical input and oversight.
8. Works with Medical Writing / Regulatory in the preparation of a variety of documents as required.
9. Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP)
10. Interacts with senior management, project management, and other departments as appropriate.
11. Provides clinical development and regulatory consulting advice both within Company and to clients as
12. Locates and interacts with outside experts as necessary.
13. Provides feedback to management on quality issues within the clinical trial team
14. Represents Company at scientific meetings as required.
15. Primary senior-level contact for customers.
16. Assumes line-management duties as needed.
Other Responsibilities :
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
The ideal candidate will need the following experience / skills to be considered :
A doctoral-level degree in medicine and must have practiced medicine and have clinical research experience. Indepth
knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical
terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of national and
ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of
spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to
meet deadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting
data to groups, and in the creation of effective documentary communication. Customer-focused with a disciplined
approach to work with excellent verbal communication and language skills. Fluency in written and spoken English.